Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Healthy Endoscopy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369963
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : May 6, 2020
Sponsor:
Collaborator:
Boston Children's Hospital
Information provided by (Responsible Party):
Betty Zheng, Seattle Children's Hospital

Brief Summary:

Researchers at Seattle Children's Research Institute want to find ways to understand gastrointestinal disease such as Inflammatory Bowel Disease (IBD), Irritable Bowel Syndrome (IBS) and Graft-Versus-Host-Disease (GVHD). We want to compare healthy cells from the gastrointestinal tract to cells from people with gastrointestinal diseases.

The investigators are looking for healthy participants 18-25 with no gastrointestinal symptoms to volunteer to have an upper and lower endoscopy and to collect blood and stool samples.

The investigators hope the information gathered in this study will help to better predict and treat these diseases in the future.

Participants who join the study will complete the following activities:

1 hour appointment at Seattle Children's Hospital to determine eligibility Blood Draw Upper and Lower Endoscopy with tissue biopsies Stool Sample collection Participants will get $600 to thank them for their time.

Participants may be eligible for this study if they meet the following requirements:

18 -25 years of age Do not have any abdominal symptoms (vomiting, diarrhea or abdominal pain) Are not on any medications (vitamins and birth control are OK) Have a BMI (body mass index) between 20-25 kg/m^2 Please note: Interested participants will have a 30 minute phone call with the study team and subsequent 1 hour appointment at Seattle Children's to determine if they meet all of the eligibility criteria.


Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Functional Gastrointestinal Disorders Procedure: Esophagogastroduodenoscopy and Colonoscopy with Biopsies

Detailed Description:

This study will enroll a cohort of healthy individuals age 18-25 to volunteer for an esophagogastroduodenoscopy and colonoscopy and will collect of gastrointestinal tissue biopsy samples, blood and stool samples.

Research Procedures include:

  • Screening questionnaires
  • Medical records review
  • Height, weight, blood pressure and temperature measurements
  • Collection of urine sample for pregnancy test and banking
  • Blood sample up to 50ccs(volume based on weight)
  • Stool sample
  • GI tissue from endoscopy (4-16 biopsies collected from esophagogastroduodenoscopy, 4 -16 biopsies collected from colonoscopy)

Data to be collected:

  • Demographics
  • Medical history
  • Pregnancy test results
  • Endoscopy results
  • Pathology results
  • Clinical data related to endoscopy
  • Clinical lab values

Study population:

The study will enroll 10 participants who meet the following criteria:

  • Age 18-25
  • No signs or symptoms of present illness
  • No known history of chronic illness
  • Not on any medications other than birth control or vitamin supplementation
  • BMI between 10-25 kg/m^2
  • Negative pregnancy test result

Objective/ Purpose:

The samples and information collected from this cohort will be used to understand the mucosal immunity of the gastrointestinal tract in individuals without gastrointestinal problems or history of chronic disease. This information will be used to study the immunology of diseases such as Inflammatory Bowel Disease, Functional Gastrointestinal Disorders and Graft vs. Host Disease.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: The Healthy Endoscopy Study
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : February 5, 2021
Estimated Study Completion Date : February 5, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Endoscopy


Intervention Details:
  • Procedure: Esophagogastroduodenoscopy and Colonoscopy with Biopsies
    Participants will have an esophagogastroduodenoscopy and colonoscopy with biopsies. Biopsies from esophagogastroduodenoscopy will not exceed 16 pinch biopsies, biopsies from colonoscopy will not exceed 16 pinch biopsies. Participants will have anesthesia for both procedures.


Primary Outcome Measures :
  1. To create a single-cell RNA atlas of healthy gastrointestinal tract from healthy participants [ Time Frame: 2 years ]
    A single-cell RNA atlas of the healthy gastrointestinal tract will be created through flow cytometry, T Cell receptor deep sequencing, single cell transcriptome analysis and whole transcriptome analysis on immune cells purified from GI tissue samples and peripheral blood.


Biospecimen Retention:   Samples With DNA
GI tissue biopsies, stool, blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

You may be eligible for this study if you are:

18 -25 years of age Do not have any abdominal symptoms (vomiting, diarrhea or abdominal pain) Are not on any medications (vitamins and birth control are OK) Have a BMI (body mas index) between 20-25 Please note: Interested participants will have a 30 minute phone call with the study team and subsequent 1 hour appointment at Seattle Children's to determine if you meet all of the eligibility criteria.

Criteria

Inclusion Criteria:

  • Age 18 -25
  • BMI between 20-25
  • Participant as no signs or symptoms of present illness
  • Participant has no known chronic illness

Exclusion Criteria:

  • On medications other than birth control or vitamins
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369963


Contacts
Layout table for location contacts
Contact: Madeline Ford, BS 2068847426 madeline.ford@seattlechildrens.org
Contact: Hengqi Zheng, MD 2068844056 betty.zheng@seattlechildrens.org

Locations
Layout table for location information
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Madeline Ford    206-884-7426    madeline.ford@seattlechildrens.org   
Contact: Hengqi Zheng, MD    2058844056    betty.zheng@seattlechildrens.org   
Principal Investigator: Hengqi Zheng, MD         
Sponsors and Collaborators
Seattle Children's Hospital
Boston Children's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Betty Zheng, MD Seattle Children's Hospital
Layout table for additonal information
Responsible Party: Betty Zheng, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT04369963    
Other Study ID Numbers: STUDY00001638
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Collaborators in Leslie Kean's lab at Boston Children's Hospital will have access to coded data and specimens. Data and specimens that may be shared include: GI tissue samples, whole blood, urine, stool, cDNA, and clinical data without identifying information.
Time Frame: Data and specimens will be stored indefinitely and may be shared at any point in the study's duration
Access Criteria: Study team members at Seattle Children's will have access to patient records and specimens with identification. Collaborator's at Boston Children's will have access to coded specimens and data at request

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Inflammatory Bowel Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Gastroenteritis